# Regulators accept shrinking of precancer as the endpoint for prevention drug approval

Source: https://onco.cc/ideas/idea-prev-precursor-endpoints-for-approval/  
OnCo record `idea-prev-precursor-endpoints-for-approval` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Few companies develop cancer prevention drugs because trials take decades. If regulators accepted validated precancer endpoints, as they do cholesterol for heart disease, industry would return.

## Summary

Few companies develop cancer prevention drugs because trials take decades, so this idea asks regulators to accept validated precursor endpoints, such as CIN2+, colorectal adenoma, Barrett's dysplasia and oral leukoplakia regression, for conditional approval with mandated long-term cancer incidence follow-up. Statin and antihypertensive development depended on surrogate endpoints, and cancer prevention has none accepted despite established links between these precursors and cancer risk. The aim is a large increase in industry-sponsored chemoprevention trials. The test is FDA and EMA guidance followed by counting trials registered before and after. Speculative in maturity, it addresses the bottlenecks Prevention we already have is not deployed and Trial design, endpoints and cost.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: A precursor-endpoint pathway triples the number of industry-sponsored chemoprevention trials within five years.
- Rationale: Statin and antihypertensive development depended on surrogate endpoints; cancer prevention has none accepted.
- Proposed test: FDA and EMA guidance, then count trials registered before and after.
- Maturity: speculative
- Actor: regulator

## Sources

- Bottleneck evidence (Prevention we already have is not deployed): Islami et al., Proportion of cancer attributable to modifiable risk factors (CA 2018): https://doi.org/10.3322/caac.21440

## Connected records

- fronts: [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [Chemoprevention & risk-reducing surgery](https://onco.cc/technologies/chemoprevention/)
- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/)
- bottlenecks: [Prevention we already have is not deployed](https://onco.cc/bottlenecks/b-prevention-adoption/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/)
- key papers: [Proportion and number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States](https://onco.cc/key-papers/paper-islami-ca-cancer-j-clin/)
- roadmaps: [Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers](https://onco.cc/roadmaps/prevention-roadmap/)

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